StrokeNCT06412237
An Exploratory Study of a Wearable Robotic Hand Orthosis
A study testing RELab tenoexo in people with Stroke, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
Upper limb deficits usually remain in 75% of the stroke survivors despite completing full rehabilitation. This is due to lack of effectiveness of rehabilitation and the degree of support and resources available. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- RELab tenoexo
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jun 2024to 27 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with first ever clinical stroke (ischaemic or haemorrhagic) with hemiplegic motor deficit(s) due to stroke as diagnosed by CT or MRI.
- Post stroke of at least 6 months with stable neurological status.
- Age 21 to 80 years of age.
- Hemiplegic pattern and shoulder abduction MRC motor power > 2/5 and elbow extension >2/5
- Has a stable home abode and a carer/NOK to assist with donning of device and supervise home based exercise
- MOCA > or equal to 22/30
- Able to give and sign informed consent at research site.
- Able to speak English
Who cannot join
- Non-stroke related causes of arm motor impairment.
- Has unstable or terminal medical conditions which may affect participation (e.g.: unresolved sepsis, postural hypotension, end stage renal failure, cancer, retroviral disease, on immunosuppressive therapy) or anticipated life expectancy of <1 year due to malignancy or neurodegenerative disorder.
- Local factors which may be worsened by intensive arm therapy: spasticity of Modified Ashworth Scale grades 3-4, skin wounds, shoulder pain Pain Scale >5/10, active/non-united fractures or arthritis or fixed joint/tissue flexion contractures of shoulder, elbow, wrist or fingers incompatible with tenoexo interface.
- Patient with severe cognitive, perceptual (include hemi-neglect), and/or emotional-behavioural issues that preclude participation.
- Experiencing moderate to severe levels of pain (Numerical Vertical Pain Scale > 5).
- Is pregnant or breast feeding. Neither the tenoexo nor the IMUs have been tested to evaluate the usage with pregnant and/or breast feeding mothers. Further, due to the length of the study, pregnancy may make it difficult to follow the study schedule.
- Have a pacemaker. Magnets are used throughout the system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Study of a Wearable Robotic Hand Orthosis in the Chronic Stroke Population in Singapore: A Clinic to Home Feasibility Trial
Upper limb deficits usually remain in 75% of the stroke survivors despite completing full rehabilitation. This is due to lack of effectiveness of rehabilitation and the degree of support and resources available.
In this study, the investigators plan to study the use of assistive technologies in chronic stroke survivors.
Read the detailed description
Assistive technologies have shown promising results in immediate improvement in functional abilities.
RELab tenoexo is a fully wearable and portable robotic hand orthoses (RHO) used for functional training. Its design support end users with functional hand opening and closing and can be applied in therapy exercises or during functional activities. While prior research demonstrated its effectiveness for spinal cord injury, it hasn't been tailored for multi-ethnic stroke populations.
This study aims to determine the feasibility and extent to which the RELab tenoexo can complement therapy training in clinic and further be used as both a training and assistive device in the home environment. In addition, it also aims to investigate the amount of upper limb usage before, during and after the training period.
- Conditions
- Stroke
- Being tested
- RELab tenoexo
- Keywords
- Hand exoskeleton robot, Robotic hand orthosis
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RELab tenoexoDevice
The RELab tenoexo is a fully wearable and portable RHO developed at the Rehabilitation Engineering Laboratory (RELab) at ETH Zurich.
| Study group | Role | What they receive |
|---|---|---|
| RELab tenoexo | Experimental | 3 weeks in clinic training (9 training sessions, two clinical assessment and 2 usability evaluations) followed by 2 weeks home training (1-hour daily training and to the extent participants desire). Lastly 1-month follow up clinical assessment and IMU data collection. Receives: Device: RELab tenoexo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test (ARAT) Score
Functional and dexterity score in the affected arm evaluated using 19 tests of motor function across 4 subsets; minimum score = 0, maximum score = 57, with higher score indicating better function.
Measured: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
Secondary outcomes (7)
Fugl-Meyer Motor Assessment (FMA) scale
Change in Fugl Meyer Motor Assessment score in the affected arm, minimum: 0, maximum: 66 with higher scores indicating greater levels of mobility function
Measured: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
Grip Strength (kg)
Measured by Digital hand-held Dynamometer (mean of 3 readings) for both hands
Measured: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
Hr-QOL scales using SS-QOL (Stroke specific Quality of Life scale)
Quality of life scale specific to stroke patients, minimum 49, maximum 245; with higher scores indicating better function.
Measured: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
EQ-5D-5L scale
Standardized measure of health-related quality of life using a 5 level scale (no problem, slight problems, moderate problems, severe problems, unable to)
Measured: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
Self-efficacy outcomes by UPSET (upper limb self-efficacy test)
Questionnaire to measure self-efficacy in various tasks after stroke
Measured: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
System Usability Scale (SUS)
To assess the overall usability of the tenoexo (effectiveness, efficiency, satisfaction), scaled from 1 (Strongly disagree) to 5 (Strongly Agree)
Measured: Week 3 (mid in-clinic training), 4 (end of in-clinic training), 8 (end of home training)
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
To evaluate user satisfaction with assistive technology, scaled from 1 (Not satisfied at all) to 5 (Very satisfied)
Measured: Week 3 (mid in-clinic training), 4 (end of in-clinic training), 8 (end of home training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start1 Jun 2024
- Primary completion27 Jan 2026
- Study completion27 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single site, pilot, feasibility study that focuses on the transition of technology use from the clinic to home environment.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tegan Plunkett, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412237
- Sponsor's protocol ID
- DSRB2023/00448
- Status last verified
- Jan 2026
- First submitted
- 8 May 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tanczak N, Plunkett TK, Lin S, Kuenzler L, Lau M, Kuah WKC, Ng CY, Gassert R, Chua K, Lambercy O. Feasibility of post-stroke hand rehabilitation supported by a soft robotic hand orthosis in-clinic and at-home. J Neuroeng Rehabil. 2025 Aug 21;22(1):183. doi: 10.1186/s12984-025-01717-6.
PubMed 40842028
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of a Wearable Robotic Hand Orthosis in the Chronic Stroke Population in Singapore: A Clinic to Home Feasibility Trial
- ClinicalTrials.gov ID
- NCT06412237
- Acronym / sponsor ID
- DSRB2023/00448
- Conditions
- Stroke
- Keywords
- Hand exoskeleton robot, Robotic hand orthosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 27 Jan 2026 (actual)
- Study completion
- 27 Jan 2026 (actual)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Upper limb deficits usually remain in 75% of the stroke survivors despite completing full rehabilitation. This is due to lack of effectiveness of rehabilitation and the degree of support and resources available.
In this study, the investigators plan to study the use of assistive technologies in chronic stroke survivors.
Detailed description
Assistive technologies have shown promising results in immediate improvement in functional abilities.
RELab tenoexo is a fully wearable and portable robotic hand orthoses (RHO) used for functional training. Its design support end users with functional hand opening and closing and can be applied in therapy exercises or during functional activities. While prior research demonstrated its effectiveness for spinal cord injury, it hasn't been tailored for multi-ethnic stroke populations.
This study aims to determine the feasibility and extent to which the RELab tenoexo can complement therapy training in clinic and further be used as both a training and assistive device in the home environment. In addition, it also aims to investigate the amount of upper limb usage before, during and after the training period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single site, pilot, feasibility study that focuses on the transition of technology use from the clinic to home environment.
| Arm | Type | Receives |
|---|---|---|
| RELab tenoexo | Experimental | Device: RELab tenoexo3 weeks in clinic training (9 training sessions, two clinical assessment and 2 usability evaluations) followed by 2 weeks home training (1-hour daily training and to the extent participants desire). Lastly 1-month follow up clinical assessment and IMU data collection. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient with first ever clinical stroke (ischaemic or haemorrhagic) with hemiplegic motor deficit(s) due to stroke as diagnosed by CT or MRI.
- Post stroke of at least 6 months with stable neurological status.
- Age 21 to 80 years of age.
- Hemiplegic pattern and shoulder abduction MRC motor power > 2/5 and elbow extension >2/5
- Has a stable home abode and a carer/NOK to assist with donning of device and supervise home based exercise
Key exclusion criteria (7 listed)
- Non-stroke related causes of arm motor impairment.
- Has unstable or terminal medical conditions which may affect participation (e.g.: unresolved sepsis, postural hypotension, end stage renal failure, cancer, retroviral disease, on immunosuppressive therapy) or anticipated life expectancy of <1 year due to malignancy or neurodegenerative disorder.
- Local factors which may be worsened by intensive arm therapy: spasticity of Modified Ashworth Scale grades 3-4, skin wounds, shoulder pain Pain Scale >5/10, active/non-united fractures or arthritis or fixed joint/tissue flexion contractures of shoulder, elbow, wrist or fingers incompatible with tenoexo interface.
- Patient with severe cognitive, perceptual (include hemi-neglect), and/or emotional-behavioural issues that preclude participation.
- Experiencing moderate to severe levels of pain (Numerical Vertical Pain Scale > 5).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RELab tenoexoThe RELab tenoexo is a fully wearable and portable RHO developed at the Rehabilitation Engineering Laboratory (RELab) at ETH Zurich. | Device | RELab tenoexo |
Primary outcome
Action Research Arm Test (ARAT) Score
Time frame: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
Functional and dexterity score in the affected arm evaluated using 19 tests of motor function across 4 subsets; minimum score = 0, maximum score = 57, with higher score indicating better function.
7 secondary outcomes
Fugl-Meyer Motor Assessment (FMA) scale
Time frame: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
Grip Strength (kg)
Time frame: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
Hr-QOL scales using SS-QOL (Stroke specific Quality of Life scale)
Time frame: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
EQ-5D-5L scale
Time frame: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
Self-efficacy outcomes by UPSET (upper limb self-efficacy test)
Time frame: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)
System Usability Scale (SUS)
Time frame: Week 3 (mid in-clinic training), 4 (end of in-clinic training), 8 (end of home training)
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST)
Time frame: Week 3 (mid in-clinic training), 4 (end of in-clinic training), 8 (end of home training)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Derived from this study: PubMed 40842028Tanczak N, Plunkett TK, Lin S, Kuenzler L, Lau M, Kuah WKC, Ng CY, Gassert R, Chua K, Lambercy O. Feasibility of post-stroke hand rehabilitation supported by a soft robotic hand orthosis in-clinic and at-home. J Neuroeng Rehabil. 2025 Aug 21;22(1):183. doi: 10.1186/s12984-025-01717-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tegan Plunkett principal investigator
Tan Tock Seng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RELab tenoexo in people with Stroke, run by Tan Tock Seng Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action Research Arm Test (ARAT) Score (time frame: Week 2 (baseline), 4 (end of in-clinic training) ,8 (end of home training) ,12 (follow-up assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06412237, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.